MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC W/SHERLOCK TLS 5F MAX TRAY DL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refx4493 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported "purple lumen leaking." additional information received (b)(6) 2022: it was reported by healthcare professional "the picc 2 lumen was placed on the patient (b)(6) 2022 in the afternoon without incident.No leaking was noted when the catheter was flushed, with that in mind usually my gloves are wet or bloody so hard to say.Later in the evening the catheter was connected to the infusion and a short while later the patient noticed his arm was wet.The product was retracted the next morning when our service was available and replaced with a new catheter in the opposite arm.The patient was here with an infection and was going home on multiple weeks of iv abx.The patient was awake and alert.No manipulation concerns with the catheter.".
Event or Problem Description
It was reported "purple lumen leaking." additional information received 02/02/2022: it was reported by healthcare professional "the picc 2 lumen was placed on the patient 1/31/22 in the afternoon without incident.No leaking was noted when the catheter was flushed, with that in mind usually my gloves are wet or bloody so hard to say.Later in the evening the catheter was connected to the infusion and a short while later the patient noticed his arm was wet.The product was retracted the next morning when our service was available and replaced with a new catheter in the opposite arm.The patient was here with an infection and was going home on multiple weeks of iv abx.The patient was awake and alert.No manipulation concerns with the catheter.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed and the cause was manufacturing-related.The product returned for evaluation was one 5fr d/l powerpicc catheter.Light usage residues were observed.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion; however, during pressurization, leakage was observed at the junction between the purple luer adapter and the syringe.Inspection of the purple luer adapter using an iso taper gauge revealed that the gauge could not be fully inserted into the luer orifice.Microscopic inspection of the purple luer adapter revealed a protrusion in the luer material within the orifice.The mold defect appeared to prevent firm attachment of the syringe, as well as full insertion of the taper gauge.The molding defect observed within the luer orifice prevented firm attachment with the syringe and resulted in leakage at the interface between the catheter and the syringe.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC W/SHERLOCK TLS 5F MAX TRAY DL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13545927
• Report Number: 3006260740-2022-00353
• Device Sequence Number: 17447011
• Product Code: LJS
• UDI-Device Identifier: 00801741035692
• UDI-Public: (01)00801741035692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9275108D
• Device Lot Number: REFX4493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Male